FDA says advice on Sinovac’s COVID-19 vaccine just a recommendation

MANILA, Philippines — The Food and Drug Administration (FDA) clarified on Tuesday that its advice on not using Sinovac’s coronavirus vaccine for healthcare workers attending to COVID-19 patients and for older people was just a recommendation.

FDA Director-General Eric Domingo reiterated that the vaccine’s efficacy rate on healthcare workers stands at 50.4 percent based on clinical trials conducted in Brazil, making it not the best vaccine to be given to medical frontliners exposed to Covid-19 patients.

READ: Health workers, seniors can’t get Sinovac shots

“However that, of course, is just a recommendation, meaning the DOH (Department of Health) can always pattern their vaccination program based on recommendations and it is not a contraindication,” he told ABS-CBN News Channel.

“We don’t say it is illegal or [they are] not allowed to use it. We are just saying that if they are gonna use it, they should know that the efficacy rate for health workers treating Covid-19 is at 50 percent,” he added.

Domingo earlier said that the Sinovac vaccine, despite getting an EUA from the local FDA, should only be administered to clinically healthy individuals aged 18 to 59 years old, as the vaccine showed higher efficacy rates in this age group.

READ: China’s Sinovac Covid-19 vaccine gets emergency use authorization

He explained that the vaccine showed a higher efficacy rate of 65.3 percent among clinically healthy people within this age bracket based on Indonesia’s clinical trials and 91.2 percent based on clinical trials in Turkey.

“Now, if the government decides to give it to health workers and health workers decide that they want to take it and not wait for another vaccine, that is also possible,” Domingo said.

“But they have to consider everything, what the vaccine can offer and what it cannot, and of course the availability of other vaccines in the near future,” the FDA chief added.

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